Prevalence of the Metabolic Syndrome in SPR Taking Antipsychotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Seoul National Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Seoul National Hospital
ClinicalTrials.gov Identifier:
NCT00569504
First received: December 6, 2007
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to assess the cross-sectional prevalence of the metabolic syndrome in patients with schizophrenia taking antipsychotics.


Condition
Metabolic Syndrome
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of the Metabolic Syndrome in Patients With Schizophrenia Taking Antipsychotics

Resource links provided by NLM:


Further study details as provided by Seoul National Hospital:

Primary Outcome Measures:
  • metabolic syndrome [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • each factor of metabolic syndrome [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood sampling


Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: September 2009
Groups/Cohorts
A, observatoin
inpatients and outpatients in Seoul National Hospital

Detailed Description:

Schizophrenic patients taking any kind of antipsychotics for at least 1 year at the Seoul National Hospital will be participated in this study.

we are planning to enroll approximately 1000 patients with schizophrenia.

For each subject

  • abdominal circumference
  • body mass index
  • lipid profile : TG, HDL-chlo, total chol
  • systolic/diastolic blood pressure
  • fasting blood glucose will be measured.

we will calculate the rates of patients who meet the criteria for the Metabolic syndrome.

  1. Abdominal obesity : absolute criteria
  2. 2 or more of followings

    1. Triglyceride ≥ 150mg/dL or ongoing treatment
    2. HDL-cholesterol < 40mg/dL (men) HDL-cholesterol < 50mg/dL (female) or ongoing treatment
    3. Hypertension 130mmHg ≥ systolic 85mmHg ≥ diastolic or ongoing treatment
    4. FBS ≥ 100mg/dL or previous diagnosis of type II DM
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

DSM-IV diagnosis of schizophrenia

Criteria

Inclusion Criteria:

  • Patients taking a same antipsychotics at least more than one year
  • schizophrenia or schizoaffective disorder

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569504

Contacts
Contact: Shi Hyun Kang, M.D. 82-2-2204-0326 drshe@hanmail.net

Locations
Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of, 139-757
Contact: Shi Hyun Kang, M.D.    82-2-2204-0326    drshe@hanmail.net   
Sponsors and Collaborators
Seoul National Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Study Director: Jong-il Lee, M.D. Seoul National Hospital
  More Information

No publications provided

Responsible Party: Shi Hyun Kang, Seoul National Hospital
ClinicalTrials.gov Identifier: NCT00569504     History of Changes
Other Study ID Numbers: snh001, PMSPSTA
Study First Received: December 6, 2007
Last Updated: June 11, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National Hospital:
schizophrenia
antipsychotics
metabolic syndrome
prevalence

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014